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Opne label trial to compare the efficacy and safety parameters of the once-a-week or once-a-month administered 7000 IU, or 30000 IU vitamin D (cholecalciferol) to a 1000 IU dosage applied daily.

Controlled, randomized, four-arm comparative, open label, multi-centric trial to compare the efficacy and safety parameters of the once-a-week or once-a-month administered 7000 IU, or 30000 IU vitamin D (cholecalciferol) to a 1000 IU dosage applied daily in vitamin D deficient patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-005232-29-HU
Enrollment
Unknown
Registered
2012-12-10
Start date
2013-02-19
Completion date
Unknown
Last updated
2014-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin D deficiency MedDRA version: 14.1 Level: PT Classification code 10047626 Term: Vitamin D deficiency System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Product Name: 1000 NE kolekalciferol (Vitamin D3) Pharmaceutical Form: Film-coated tablet INN or Proposed INN: cholecalciferol Other descriptive name: CHOLECALCIFEROL Concentration unit: IU internatio

Sponsors

Pharma Patent Kft
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - age =65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: - hypercalcaemia/ se Ca levels out of 2.20-2.60 mmol/L range

Design outcomes

Primary

MeasureTime frame
Main Objective: Comparison efficacy by 25OHD and safety parameters of a daily single dose of 1000 IU to a once-a week or once-a month administered 7000 IU or 30000 IU vitamin D, respectively. ;Secondary Objective: Comparison efficacy by 25OHD and safety parameters of a daily single dose of 1000 IU to a once-a week administered 7000 IU or 30000 IU vitamin D. Register and compare the safety parameters for each group. ;Primary end point(s): There are 3 independent endpoints set: based on the changes in 25OHD versus to baseline, in each group, and compared to the group of 1000 IU daily dosage applied. 1000 IU /day vs. 7000 IU/ week, eqv. 1000 IU/ day vs 30000 IU/ month egv. 1000 IU /day vs 30000 IU/week: superioirty;Timepoint(s) of evaluation of this end point: 0 vs 90 days—

Secondary

MeasureTime frame
Secondary end point(s): Frequency of Side effects for each group compared to group "A". Changes of serum PTH, Ca, urinary Ca in each and between group. ;Timepoint(s) of evaluation of this end point: On 30 and 90 days—

Countries

Hungary

Contacts

Public ContactIroda-törzskönyvezés

Pharma Patent Kft

clinical@pharmapatent.hu+361630 6182

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026